Shortest Development Time for Breakthrough Status Drugs

Shorter development time for breakthrough, non-fast-track versus fast-track, non-breakthrough drugs

December 6, 2017 (Last Updated)

TUESDAY, Dec. 5, 2017 (HealthDay News) -- Drugs with breakthrough status have the shortest median development time, according to a research letter published in the Dec. 5 issue of the Journal of the American Medical Association.

Thomas J. Hwang, from Brigham and Women's Hospital in Boston, and colleagues examined development times for drugs enrolled in fast-track or breakthrough programs. Clinical development times were calculated as the time from the Investigational New Drug application to first Food and Drug Administration approval.

Sixty percent of the 174 new drug approvals were in one or more expedited programs. The researchers found that the expedited programs included priority review (90 drugs), accelerated approval (26 drugs), fast-track (63 drugs), and breakthrough (29 drugs). The median development time was 7.1 years for drugs in at least one expedited program, compared with 8.0 years for non-expedited drugs (P = 0.04). Development times were not significantly different for drugs with priority review or accelerated approval versus no expedited program, for non-breakthrough, non-fast-track drugs (8.2 versus 8.0 years; P = 0.35). Fast-track versus non-fast-track drugs (7.0 versus 8.0 years; P = 0.03) and breakthrough versus non-breakthrough drugs (4.8 versus 8.0 years; P < 0.001) had shorter development times, regardless of other programs. Shorter development times were seen for breakthrough, non-fast-track drugs versus fast-track, non-breakthrough drugs (4.7 versus 7.1 years; P = 0.001).

"The shortest median development time of 4.8 years (32 percent shorter than fast-track drugs) was observed for drugs with breakthrough status," the authors write.

One author disclosed financial ties to Blackstone and Bain Capital, which have invested in health care companies.